Catheter pump with off-set motor position

ABSTRACT

A catheter pump assembly is provided that includes an elongate body, an elongate flexible shaft disposed in the elongate body, and an impeller coupled with the distal end of the elongate flexible shaft. The drive system includes a drive component, a motor and a tension member. The tension member is coupled with the motor and the drive component and to cause the drive component to rotate, and thereby to cause the impeller to rotate.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Patent ApplicationNo. 61/979,876, filed Apr. 15, 2014, the contents of which areincorporated by reference herein in their entirety and for all purposes.

BACKGROUND OF THE INVENTION Field of the Invention

This application is directed to heart pumps that can be appliedpercutaneously and driven extracorporeally with a motor.

Description of the Related Art

Heart disease is a major health problem that has high mortality rate.Physicians increasingly use mechanical circulatory support systems fortreating heart failure. The treatment of acute heart failure requires adevice that can provide support to the patient quickly. Physiciansdesire treatment options that can be deployed quickly andminimally-invasively.

Intra-aortic balloon pumps (IABP) are currently the most common type ofcirculatory support devices for treating acute heart failure. IABPs arecommonly used to treat heart failure, such as to stabilize a patientafter cardiogenic shock, during treatment of acute myocardial infarction(MI) or decompensated heart failure, or to support a patient during highrisk percutaneous coronary intervention (PCI). Circulatory supportsystems may be used alone or with pharmacological treatment.

In a conventional approach, an IABP is positioned in the aorta andactuated in a counterpulsation fashion to provide partial support to thecirculatory system. More recently minimally-invasive rotary blood pumphave been developed in an attempt to increase the level of potentialsupport (i.e., higher flow). A rotary blood pump is typically insertedinto the body and connected to the cardiovascular system, for example,to the left ventricle and the ascending aorta to assist the pumpingfunction of the heart. Other known applications pumping venous bloodfrom the right ventricle to the pulmonary artery for support of theright side of the heart. An aim of acute circulatory support devices isto reduce the load on the heart muscle for a period of time, tostabilize the patient prior to heart transplant or for continuingsupport.

There is a need for improved mechanical circulatory support devices fortreating acute heart failure. Fixed cross-section ventricular assistdevices designed to provide near full heart flow rate are either toolarge to be advanced percutaneously (e.g., through the femoral arterywithout a cutdown) or provide insufficient flow.

There is a need for a pump with improved performance and clinicaloutcomes. There is a need for a pump that can provide elevated flowrates with reduced risk of hemolysis and thrombosis. There is a need fora pump that can be inserted minimally-invasively and provide sufficientflow rates for various indications while reducing the risk of majoradverse events. In one aspect, there is a need for a heart pump that canbe placed minimally-invasively, for example, through a 15FR or 12FRincision. In one aspect, there is a need for a heart pump that canprovide an average flow rate of 4 Lpm or more during operation, forexample, at 62 mmHg of head pressure. While the flow rate of a rotarypump can be increased by rotating the impeller faster, higher rotationalspeeds are known to increase the risk of hemolysis, which can lead toadverse outcomes and in some cases death. Accordingly, in one aspect,there is a need for a pump that can provide sufficient flow atsignificantly reduced rotational speeds. These and other problems areovercome by the inventions described herein.

Further, there is a need for a motor configured to drive an operativedevice, e.g., a impeller, at a distal portion of the pump. It can beimportant for the motor to be configured to allow for percutaneousinsertion of the pump's operative device.

SUMMARY OF THE INVENTION

In various embodiments, to provide improved performance as discussedabove, a drive shaft or cable is required to operate at a highrotational speed. Such operating conditions may be greatly improved byproviding structures that enable more precise rotational positioning ofone or more components. Such operating conditions may be greatlyimproved by providing structures that provide more symmetrical flow oflubricant at least adjacent to or around rotational interfaces includingthose adjacent to speed or torque transfer members, such as gears,sprockets and other mechanical interface or rotating magnet assembliesor other rotors, such as at the proximal end of the drive shaft.

In one embodiment, a catheter pump assembly is provided that includes anelongate body, an elongate flexible shaft, and an impeller. The elongatebody has a proximal end, a distal end and at least one lumen extendingtherebetween. The elongate flexible shaft has a proximal end and adistal end. The elongate flexible shaft extends through the lumen. Theimpeller is coupled with the distal end of the elongate flexible shaft.The catheter pump assembly also includes a driven component, a motor,and a tension member. The driven component is coupled with the elongateflexible member. The tension member is coupled with the motor and withthe driven component to cause the driven component to rotate when themotor rotates and thereby to cause the elongate flexible shaft and theimpeller to rotate.

In one embodiment, a catheter pump assembly is provided that includes acatheter assembly and a drive system. The catheter assembly includes anelongate body, an elongate flexible shaft, and an impeller. The elongatebody has a proximal end and a distal end and at least one lumenextending therebetween. The elongate flexible shaft extends through thelumen. The elongate flexible shaft has a proximal end and a distal end.The impeller is coupled with the distal end of the elongate flexibleshaft. The catheter assembly includes a first transmission housingdisposed at the proximal end of the elongate body. A driven component isjournaled in the first transmission housing. The driven component iscoupled with the proximal end of the elongate flexible shaft. The drivesystem includes a second transmission housing, a drive component, amotor and a tension member. The second transmission housing has anenclosed space therein and an open end configured to receive the firsttransmission housing. The drive component is journaled in the secondtransmission housing and is configured to engage the driven componentwhen the first transmission housing is received in the open end of thesecond transmission housing. The tension member is coupled with themotor and extends within the second transmission housing to engage thedrive component and to cause the drive component to rotate, and therebyto cause the driven component to rotate.

In another embodiment, a catheter pump assembly is provided thatincludes a catheter assembly, an operating fluid system, and a drivesystem. The catheter assembly has an elongate body, an elongate flexibleshaft, an impeller, and a driven component. The elongate body has aproximal end and a distal end, a first lumen and a second lumenextending between the proximal and distal ends. The elongate flexibleshaft has a proximal end and a distal end and extends through the firstlumen. The impeller is disposed distal of the distal end of the elongateflexible shaft. The driven component is coupled with the proximal end ofthe elongate flexible shaft and is supported for rotation adjacent tothe proximal end of the elongate body. An outflow port is disposedproximal of the driven component. The operating fluid system includes asource of operating fluid in communication with the second lumen of theelongate body. The operating fluid is flowable into the second lumen anddistally within the elongate body and thereafter proximally in the firstlumen to cool and/or lubricate the elongate flexible drive shaft and thedriven component. The operating fluid may be referred to herein as aninfusate or an infusant. The drive system has a motor and a transmissionfor transferring torque to the driven component. The motor is disposedlaterally of the outflow port such that the operating fluid can beremoved from the catheter assembly through the outflow port proximallyof the driven component without flowing through the motor.

In another embodiment, a catheter pump assembly is provided thatincludes an elongate flexible shaft and a transmission housing. Theelongate flexible shaft extends through a lumen of a catheter body. Animpeller is disposed distal of a distal end of the elongate flexibleshaft. A driven component is coupled with the proximal end of theelongate flexible shaft and is supported for rotation relative to thecatheter body. The transmission housing has a follower shaft disposedtherein. The follower shaft has a proximal end and a distal end. Thefollower shaft is supported by a bearing at each of the proximal anddistal ends thereof. A drive component is mounted on the follower shaftadjacent to the distal end thereof. A speed and torque transfer memberis mounted adjacent to the proximal end of the follower shaft. The speedand torque transfer member is configured to transfer a torque appliedthereto to the follower shaft and thereby to the drive component andthereby to the driven component to rotate the elongate flexible shaftand the impeller.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete appreciation of the subject matter of this applicationand the various advantages thereof can be realized by reference to thefollowing detailed description, in which reference is made to theaccompanying drawings in which:

FIG. 1 illustrates one embodiment of a catheter pump configured forpercutaneous application and operation;

FIG. 2 is a plan view of one embodiment of a catheter adapted to be usedwith the catheter pump of FIG. 1;

FIG. 3 show a distal portion of the catheter system similar to that ofFIG. 2 in position within the anatomy;

FIG. 4 is a schematic view of a catheter assembly and a drive assembly;

FIG. 4A is an enlarged view of a priming apparatus shown in FIG. 4;

FIG. 5 is a three dimensional (3D) perspective view of a drive assemblyas the drive assembly is being coupled to a driven assembly;

FIG. 6 is a plan view of the drive assembly coupled and secured to thedriven assembly;

FIG. 7 is a 3D perspective view of a motor assembly including the driveassembly of FIG. 6, wherein various components have been removed forease of illustration;

FIG. 7A is a schematic view of another embodiment of a motor assemblythat can be used to drive an impeller of a catheter assembly;

FIG. 8 is a plan view of the motor assembly that illustrates a motor, adrive magnet and a driven magnet;

FIG. 9 is a 3D perspective view of a first securement device configuredto secure the drive assembly to the driven assembly;

FIGS. 10A-10C are 3D perspective views of a second securement deviceconfigured to secure the drive assembly to the driven assembly;

FIG. 11 illustrates a side schematic view of a motor assembly accordingto another embodiment;

FIGS. 12A-12B illustrates side schematic views of a motor assemblyaccording to yet another embodiment;

FIG. 13 is a side view of a distal tip member disposed at a distal endof the catheter assembly, according to one embodiment;

FIG. 14 is a side cross-sectional view of a distal tip member disposedat a distal end of the catheter assembly, according to anotherembodiment.

FIG. 15 illustrates a catheter pump assembly including an off-set motordrive system.

FIG. 16 is a partial assembly view of an embodiment with separatehousings enclosing portions of a motor assembly and a transmissionassembly.

FIG. 17 is a partial assembly view showing internal components of oneembodiment of a transmission assembly.

More detailed descriptions of various embodiments of components forheart pumps useful to treat patients experiencing cardiac stress,including acute heart failure, are set forth below.

DETAILED DESCRIPTION

This application is directed to apparatuses for inducing motion of afluid relative to the apparatus. For example, an operative device, suchas an impeller, can be coupled at a distal portion of the apparatus. Inparticular, the disclosed embodiments generally relate to variousconfigurations for a motor adapted to drive an impeller at a distal endof a catheter pump, e.g., a percutaneous heart pump. The disclosed motorassembly may be disposed outside the patient in some embodiments. Inother embodiments, the disclosed motor assembly can be miniaturized andsized to be inserted within the body. FIGS. 1-3 show aspects of acatheter pump 10 that can provide high performance flow rates. The pump10 includes a motor driven by a controller 22. The controller 22 directsthe operation of the motor 14 and an infusion or operating fluid system26 that supplies a flow of operating fluid or infusate in the pump 10.

A catheter system 80 that can be coupled with the motor 14 houses animpeller within a distal portion thereof. In various embodiments, theimpeller is rotated remotely by the motor 14 when the pump 10 isoperating. For example, the motor 14 can be disposed outside thepatient. In some embodiments, the motor 14 is separate from thecontroller 22, e.g., to be placed closer to the patient. In otherembodiments, the motor 14 is part of the controller 22. In otherembodiments, the controller 22 is integrated into a patient-adjacentmotor assembly 14. In still other embodiments, the motor is miniaturizedto be insertable into the patient. Such embodiments allow a shaftconveying torque to an impeller or other operating element at the distalend to be much shorter, e.g., shorter than the distance from the aorticvalve to the aortic arch (about 5 cm or less). Some examples ofminiaturized motors catheter pumps and related components and methodsare discussed in U.S. Pat. Nos. 5,964,694; 6,007,478; 6,178,922; and6,176,848, all of which are hereby incorporated by reference herein intheir entirety for all purposes. Various embodiments of a motor aredisclosed herein, including embodiments having separate drive and drivenassemblies to enable the use of a guidewire guide passing through thecatheter pump. As explained herein, a guidewire guide can facilitatepassing a guidewire through the catheter pump for percutaneous deliveryof the pump's operative device to a patient's heart. In someembodiments, a motor is separated from a drive component employing adrive belt or other tension member or off-set transmission arrangement.Such further embodiments can improve access to the proximal end of acatheter assembly of the pump 10. Such further embodiments also canimprove operation of the rotating components of the pump 10.

FIG. 3 illustrates one use of the catheter pump 10. A distal portion ofthe pump 10, which can include an impeller assembly 92, is placed in theleft ventricle LV of the heart to pump blood from the LV into the aorta.The pump 10 can be used in this way to treat patients with a wide rangeof conditions, including cardiogenic shock, myocardial infarction, andother cardiac conditions, and also to support a patient during aprocedure such as percutaneous coronary intervention. One convenientmanner of placement of the distal portion of the pump 10 in the heart isby percutaneous access and delivery using the Seldinger technique orother methods familiar to cardiologists. These approaches enable thepump 10 to be used in emergency medicine, a catheter lab and in othernon-surgical settings. Modifications can also enable the pump 10 tosupport the right side of the heart. Example modifications that could beused for right side support include providing delivery features and/orshaping a distal portion that is to be placed through at least one heartvalve from the venous side, such as is discussed in U.S. Pat. Nos.6,544,216; 7,070,555; and US 2012-0203056A1, all of which are herebyincorporated by reference herein in their entirety for all purposes.

FIG. 2 shows features that facilitate small blood vessel percutaneousdelivery and high performance, including up to and in some casesexceeding normal cardiac output in all phases of the cardiac cycle. Inparticular, the catheter system 80 includes a catheter body 84 and asheath assembly 88. The catheter body 84 can include an elongate bodywith proximal and distal end, in which a length of the body 84 enablesthe pump 10 to be applied to a patient from a peripheral vascularlocation. The impeller assembly 92 is coupled with the distal end of thecatheter body 84. The impeller assembly 92 is expandable andcollapsible. In the collapsed state, the distal end of the cathetersystem 80 can be advanced to the heart, for example, through an artery.In the expanded state the impeller assembly 92 is able to pump blood athigh flow rates. FIGS. 2 and 3 illustrate the expanded state. Thecollapsed state can be provided by advancing a distal end 94 of anelongate body 96 distally over the impeller assembly 92 to cause theimpeller assembly 92 to collapse. This provides an outer profilethroughout the catheter assembly 80 that is of small diameter, forexample, to a catheter size of about 12.5 FR in various arrangements.

In some embodiments, the impeller assembly 92 includes a self-expandingmaterial that facilitates expansion. The catheter body 84 on the otherhand preferably is a polymeric body that has high flexibility.

The mechanical components rotatably supporting the impeller within theimpeller assembly 92 permit high rotational speeds while controllingheat and particle generation that can come with high speeds. Theinfusion system 26 delivers a cooling and lubricating solution(sometimes referred to herein as an operating fluid) to the distalportion of the catheter system 80 for these purposes. However, the spacefor delivery of this fluid is extremely limited. Some of the space isalso used for return of the operating fluid. Providing secure connectionand reliable routing of operating fluid into and out of the catheterassembly 80 is critical and challenging in view of the small profile ofthe catheter body 84.

When activated, the catheter pump system can effectively increase theflow of blood out of the heart and through the patient's vascularsystem. In various embodiments disclosed herein, the pump can beconfigured to produce a maximum flow rate (e.g. low mm Hg) of greaterthan 4 Lpm, greater than 4.5 Lpm, greater than 5 Lpm, greater than 5.5Lpm, greater than 6 Lpm, greater than 6.5 Lpm, greater than 7 Lpm,greater than 7.5 Lpm, greater than 8 Lpm, greater than 9 Lpm, or greaterthan 10 Lpm. In various embodiments, the pump can be configured toproduce an average flow rate at 62 mmHg of greater than 2 Lpm, greaterthan 2.5 Lpm, greater than 3 Lpm, greater than 3.5 Lpm, greater than 4Lpm, greater than 4.25 Lpm, greater than 4.5 Lpm, greater than 5 Lpm,greater than 5.5 Lpm, or greater than 6 Lpm.

Various aspects of the pump and associated components are similar tothose disclosed in U.S. Pat. Nos. 7,393,181; 8,376,707; 7,841,976;7,022,100; and 7,998,054, and in U.S. Pub. Nos. 2011/0004046;2012/0178986; 2012/0172655; 2012/0178985; and 2012/0004495, the entirecontents of each of which are incorporated herein for all purposes byreference. In addition, this application incorporates by reference inits entirety and for all purposes the subject matter disclosed in eachof the following patent publications: Publication No. 2013/0303970,entitled “DISTAL BEARING SUPPORT,” filed on Mar. 13, 2013; ApplicationNo. 61/780,656, entitled “FLUID HANDLING SYSTEM,” filed on Mar. 13,2013; Publication No. 2013/0303969, entitled “SHEATH SYSTEM FOR CATHETERPUMP,” filed on Mar. 13, 2013; Publication No. 2013/0303830, entitled“IMPELLER FOR CATHETER PUMP,” filed on Mar. 13, 2013; and PublicationNo. 2014/0012065, entitled “CATHETER PUMP,” filed on Mar. 13, 2013.

Another example of a catheter assembly 100A is illustrated in FIG. 4.Embodiments of the catheter pump of this application can be configuredwith a motor that is capable of coupling to (and in some arrangementsoptionally decoupling from) the catheter assembly 100A. This arrangementprovides a number of advantages over a non-disconnectable motor. Forexample, access can be provided to a proximal end of the catheterassembly 100A prior to or during use. In one configuration, a catheterpump is delivered over a guidewire. The guidewire may be convenientlyextended through the entire length of the catheter assembly 100A and outof a proximal portion thereof that is completely enclosed in a coupledconfiguration. For this approach, connection of the proximal portion ofthe catheter assembly 100A to a motor housing can be completed after aguidewire has been used to guide the operative device of the catheterpump to a desired location within the patient, e.g., to a chamber of thepatient's heart. In other embodiments, discussed below in connectionwith FIGS. 15-17, a housing enclosing a portion of a motor or driveassembly provides proximal end access to a guidewire lumen or to one ora plurality of ports or conduits for removing fluids from the assembly100A. In one embodiment, the connection between the motor housing andthe catheter assembly is configured to be permanent, such that thecatheter assembly, the motor housing and the motor are disposablecomponents. However, in other implementations, the coupling between themotor housing and the catheter assembly is disengageable, such that themotor and motor housing can be decoupled from the catheter assemblyafter use. In such embodiments, the catheter assembly distal of themotor can be disposable, and the motor and motor housing can bere-usable. One will appreciate from the description herein that themotor can be configured in various manner such that the connection tothe rotating shaft can be made within the motor housing or adjacent thehousing depending on the application and design parameters. For example,it may be desired to configure the motor so it can be re-used as capitalequipment and the catheter is disposable.

Moving from the distal end of the catheter assembly 100A of FIG. 4 tothe proximal end, a priming apparatus 1400 can be disposed over animpeller assembly 116A. As explained above, the impeller assembly 116Acan include an expandable cannula or housing and an impeller with one ormore blades. As the impeller rotates, blood can be pumped proximally (ordistally in some implementations) to function as a cardiac assistdevice.

FIG. 4 also shows one example of a priming apparatus 1400 disposed overthe impeller assembly 116A near the distal end 170A of the elongate body174A. FIG. 4A is an enlarged view of the priming apparatus 1400 shown inFIG. 4. The priming apparatus 1400 can be used in connection with aprocedure to expel air from the impeller assembly 116A, e.g., any airthat is trapped within the housing or that remains within the elongatebody 174A near the distal end 170A. For example, the priming proceduremay be performed before the pump is inserted into the patient's vascularsystem, so that air bubbles are not allowed to enter and/or injure thepatient. The priming apparatus 1400 can include a primer housing 1401configured to be disposed around both the elongate body 174A and theimpeller assembly 116A. A sealing cap 1406 can be applied to theproximal end 1402 of the primer housing 1401 to substantially seal thepriming apparatus 1400 for priming, i.e., so that air does notproximally enter the elongate body 174A and also so that priming fluiddoes not flow out of the proximal end of the housing 1401. The sealingcap 1406 can couple to the primer housing 1401 in any way known to askilled artisan. However, in some embodiments, the sealing cap 1406 isthreaded onto the primer housing by way of a threaded connector 1405located at the proximal end 1402 of the primer housing 1401. The sealingcap 1406 can include a sealing recess disposed at the distal end of thesealing cap 1406. The sealing recess can be configured to allow theelongate body 174A to pass through the sealing cap 1406.

The priming operation can proceed by introducing fluid into the sealedpriming apparatus 1400 to expel air from the impeller assembly 116A andthe elongate body 174A. Fluid can be introduced into the primingapparatus 1400 in a variety of ways. For example, fluid can beintroduced distally through the elongate body 174A into the primingapparatus 1400. In other embodiments, an inlet, such as a luer, canoptionally be formed on a side of the primer housing 1401 to allow forintroduction of fluid into the priming apparatus 1400.

A gas permeable membrane can be disposed on a distal end 1404 of theprimer housing 1401. The gas permeable membrane can permit air to escapefrom the primer housing 1401 during priming.

The priming apparatus 1400 also can advantageously be configured tocollapse an expandable portion of the catheter assembly 100A. The primerhousing 1401 can include a funnel 1415 where the inner diameter of thehousing decreases from distal to proximal. The funnel 1415 may be gentlycurved such that relative proximal movement of an impeller housing ofthe impeller assembly 116A causes the impeller housing to be collapsedby the funnel 1415. During or after the impeller housing has been fullycollapsed, the distal end 170A of the elongate body 174A can be moveddistally relative to the collapsed housing. After the impeller housingis fully collapsed and retracted into the elongate body 174A of thesheath assembly, the catheter assembly 100A can be removed from thepriming housing 1400 before a percutaneous heart procedure is performed,e.g., before the pump is activated to pump blood. The embodimentsdisclosed herein may be implemented such that the total time forinfusing the system is minimized or reduced. For example, in someimplementations, the time to fully infuse the system can be about sixminutes or less. In other implementations, the time to infuse can beabout three minutes or less. In yet other implementations, the totaltime to infuse the system can be about 45 seconds or less. It should beappreciated that lower times to infuse can be advantageous for use withcardiovascular patients.

With continued reference to FIG. 4, the elongate body 174A extendsproximally from the impeller assembly 116A to an infusate device 195configured to allow for infusate to enter the catheter assembly 100A andfor waste fluid to leave the catheter assembly 100A. A catheter body120A (which also passes through the elongate body 174A) can extendproximally and couple to a driven assembly 201. The driven assembly 201can be configured to receive torque applied by a drive assembly 203,which is shown as being decoupled from the driven assembly 201 and thecatheter assembly 100A in FIG. 4. Although not shown in FIG. 4, a driveshaft can extend from the driven assembly 201 through the catheter body120A to couple to an impeller shaft at or proximal to the impellerassembly 116A. The catheter body 120A can pass within the elongatecatheter body 174A such that the external catheter body 174A can axiallytranslate relative to the catheter body 120A.

In addition, FIG. 4 illustrates a guidewire 235 extending from aproximal guidewire opening 237 in the driven assembly 201. Beforeinserting the catheter assembly 100A into a patient, a clinician mayinsert the guidewire 235 through the patient's vascular system to theheart to prepare a path for the operative device (e.g., the impellerassembly 116A) to the heart. In some embodiments, the catheter assemblycan include a guidewire guide tube (see FIG. 12) passing through acentral internal lumen of the catheter assembly 100A from the proximalguidewire opening 237. The guidewire guide tube can be pre-installed inthe catheter assembly 100A to provide the clinician with a preformedpathway along which to insert the guidewire 235.

In one approach, a guidewire is first placed in a conventional way,e.g., through a needle into a peripheral blood vessel, and along thepath between that blood vessel and the heart and into a heart chamber,e.g., into the left ventricle. Thereafter, a distal end opening of thecatheter assembly 100A or guidewire guide tube 312 (discussed below inconnection with FIGS. 13 and 14) can be advanced over the proximal endof the guidewire 235 to enable delivery to the catheter assembly 100A.After the proximal end of the guidewire 235 is urged proximally withinthe catheter assembly 100A and emerges from the guidewire opening 237and/or guidewire guide, the catheter assembly 100A can be advanced intothe patient. In one method, the guidewire guide is withdrawn proximallywhile holding the catheter assembly 100A. The guidewire guide tube 312is taken off of the catheter assembly 100A so that guidewire lumens fromthe proximal end to the distal end of the catheter assembly 100A aredirectly over the guidewire.

Alternatively, the clinician can thus insert the guidewire 235 throughthe proximal guidewire opening 237 and urge the guidewire 235 along theguidewire guide tube until the guidewire 235 extends from a distalguidewire opening (not shown) in the distal end of the catheter assembly100A. The clinician can continue urging the guidewire 235 through thepatient's vascular system until the distal end of the guidewire 235 ispositioned in the desired chamber of the patient's heart. As shown inFIG. 4, a proximal end portion of the guidewire 235 can extend from theproximal guidewire opening 237. Once the distal end of the guidewire 235is positioned in the heart, the clinician can maneuver the impellerassembly 116A over the guidewire 235 until the impeller assembly 116Areaches the distal end of the guidewire 235 in the heart. The cliniciancan remove the guidewire 235 and the guidewire guide tube. The guidewireguide tube can also be removed before or after the guidewire 235 isremoved in some implementations.

After removing at least the guidewire 235, the clinician can activate amotor to rotate the impeller and begin operation of the pump.

One problem that arises when using the guidewire 235 to guide theoperative device to the heart is that a central lumen or tube (e.g., aguidewire guide) is typically formed to provide a path for the guidewire235. In some implementations, it may be inconvenient or inoperable toprovide a motor or drive assembly having a lumen through which theguidewire 235 can pass. Moreover, in some implementations, it may bedesirable to provide the motor or drive assembly separate from thecatheter assembly 100A, e.g., for manufacturing or economic purposes.Thus, it can be advantageous to provide a means to couple the driveassembly 203 to the driven assembly 201, while enabling the use of aguidewire guide through which a guidewire may be passed. Preferably, thedrive assembly 203 can be securely coupled to the driven assembly 201such that vibratory, axial, or other external forces do not decouple thedrive assembly 203 from the driven assembly 201 during operation. Asdiscussed further below, separating the motor 14 from the drivenassembly 201 enhances smooth operation by reducing vibrations in thedriven assembly 201 and also provides better access to the proximal endof the catheter assembly 100A. In various implementations, the motor 14can be laterally offset form the driven assembly 201. Laterally offsetincludes arrangements where the motor 14 is disposed to the side of arotational axis of the driven assembly 201. For example, the motor 14can have an output shaft that rotates about an axis that is parallel tothe rotational axis of the driven assembly 201. As another example, aplane perpendicular to and intersecting the output shaft of the motor 14and/or perpendicular to and intersecting a drive component coupled withthe output shaft can intersect a drive component disposed in the drivenassembly 201. In other implementations, the motor 14 can be axiallyspaced form the driven assembly 201. The motor 14 also can berotationally separate from the driven assembly. These and other similararrangements are advantageous at least in preventing or reducing thetendency of axial, lateral, vibrational, and other operational forcesfrom being transferred between the motor and the driven assembly 201 orcomponents thereof, specifically from the motor 14 to the drivencomponent 201 and thereby to the working end of the catheter pump 10 andvariations thereof. Moreover, the coupling should preferably allow amotor to operate effectively so that the drive shaft is rotated at thedesired speed and with the desired torque.

FIG. 5 illustrates one embodiment of a motor assembly 206 as the drivenassembly 201 is being coupled to the drive assembly 203. The drivenassembly 201 can include a flow diverter 205 and a flow diverter housing207 that houses the flow diverter 205. The flow diverter 205 can beconfigured with a plurality of internal cavities, passages, and channelsthat are configured to route fluid to and from the patient during amedical procedure. As discussed below, an infusate can be directed intothe flow diverter from a source of infusate. The infusate is a fluidthat flows into the catheter body 120A to provide useful benefits, suchas cooling moving parts and keeping blood from entering certain parts ofthe catheter assembly 100A. The infusate is diverted distally by flowchannels in the flow diverter 205. Some of the infusate that flowsdistally is re-routed back through the catheter body 120A and may bediverted out of the catheter assembly 100A by the flow diverter 205.Moreover, a driven magnet 204 can be disposed within the flow diverter205 in various embodiments. For example, the driven magnet 204 can bejournaled for rotation in a proximal portion of the flow diverterhousing 207. The proximal portion can project proximally of a proximalface of a distal portion of the flow diverter housing 207. In otherembodiments, the driven magnet 204 can be disposed outside the flowdiverter 205. The driven magnet 204 can be configured to rotate freelyrelative to the flow diverter 205 and/or the flow diverter housing 207.The catheter body 120A can extend from a distal end of the flow diverterhousing 207. Further, a drive shaft 208 can pass through the catheterbody 120A from the proximal end of the flow diverter housing 207 to thedistal end 170A of the elongate body 174A. The drive shaft 208 can beconfigured to drive the impeller located at the distal end of thecatheter assembly 100A. In some embodiments, a distal end of the driveshaft 208 can couple to an impeller shaft, which rotates the impeller.

The drive assembly 203 can include a drive housing 211A or a motorhousing 211 having an opening 202 in a cap 212 of the motor housing 211.The motor housing 211 can also have a sliding member 213, which can beconfigured to couple to the patient's body by way of, e.g., a connector291 coupled to an adhesive or bandage on the patient's body. Because themotor and motor housing 211 can have a relatively high mass, it can beimportant to ensure that the motor housing 211 is stably supported. Inone implementation, therefore, the motor housing 211 can be supported bythe patient's body by way of the sliding member 213 and the connector291 shown in FIG. 4. The sliding member 213 can slide along a track 214located on a portion of the motor housing 211, such that relative motionbetween the motor assembly 206 and the patient does not decouple thesliding member 213 from the patient's body. The sliding member 213 andconnector 291 can therefore be configured to provide a structuralinterface between the motor housing 206 and a platform for supportingthe motor housing 211. As explained above, in some arrangements, theplatform supporting the motor housing 211 can be the patient, since themotor housing 211 may be positioned quite close to the insertion point.In other arrangements, however, the platform supporting the motorhousing 211 may be an external structure.

To couple the drive assembly 203 to the driven assembly 201, theclinician or user can insert the proximal portion of the flow diverter205 into the opening 202 in the cap 212 of the motor housing 212. Afterpassing through the opening 202, the proximal portion of the flowdiverter can reside within a recess formed within the motor housing 211.In some implementations, a securement device is configured to lock orsecure the drive assembly 203 to the driven assembly 201 once the drivenassembly 201 is fully inserted into the drive assembly 203. In otherimplementations, the securement device can be configured to secure thedrive assembly 203 to the driven assembly 201 by inserting the drivenassembly 201 into the drive assembly 203 and then rotating the driveassembly 203 with respect to the driven assembly 201. In someimplementations, coupling the drive assembly 203 to the driven assembly201 may be irreversible, such that there may be no release mechanism todecouple the drive assembly 203 from the driven assembly 201. Inimplementations without a release mechanism, the catheter assembly 100A(including the driven assembly 201) and the motor housing 211 may bedisposable components. In other implementations, however, a releasemechanism may be provided to remove the drive assembly 203 from thedriven assembly 201. The drive assembly 203 can thereby be used multipletimes in some embodiments.

FIG. 6 illustrates the motor assembly 206 in the assembled state, e.g.,after the drive assembly 203 has been secured to the driven assembly201. When the drive assembly 203 is activated (e.g., a motor isactivated to rotate an output shaft), the driven assembly 201, which isoperably coupled to the drive assembly, is also activated. The activateddriven assembly can cause the drive shaft 208 to rotate, which in turncauses the impeller to rotate to thereby pump blood through the patient.

FIGS. 7-8 illustrate the motor assembly 206 with one wall of the motorhousing 211 removed so that various internal components in the housing211 can be better illustrated. A motor 220 can be positioned within thehousing 211 and mounted by way of a motor mount 226. The motor 220 canoperably couple to a drive magnet 221. For example, the motor 220 caninclude an output shaft 222 that rotates the drive magnet 221. In someimplementations, the drive magnet 221 can rotate relative to the motormount 226 and the motor housing 211. Further, in some arrangements, thedrive magnet 221 can be free to translate axially between the motormount and a barrier 224. One advantage of the translating capability isto enable the drive magnet 221 and the driven magnet 204 to self-alignby way of axial translation. The barrier 224 can be mounted to the motorhousing 211 and at least partially within the cap 212 to support atleast the drive magnet 221. In other implementations, the drive assembly203 can comprise a plurality of motor windings configured to inducerotation of the drive magnet 221. In still other embodiments, motorwindings can operate directly on a driven magnet within the drivenassembly 201. For example, the windings can be activated in phases tocreate an electric and/or magnetic field or fields and thereby commutatethe driven magnet. Examples of such a configuration are described inU.S. Pat. Nos. 4,846,152 to Wampler et al. and U.S. Pat. No. 4,895,557to Moise et al.

FIG. 7A illustrates further details of a frameless motor assembly 14A inwhich windings are used to induce rotation of a rotor 228. The rotor 228can include one or more magnets and thus may correspond to the drivenmagnet 204 or may be coupled with the drive magnet 221. The rotor 228 ispositioned within a stator or armature assembly 230. The armatureassembly 230 can take any suitable form, such as including a ring-shapedor cylindrical hub in which a plurality of windings 232 are disposed.The windings 232 are coupled by a lead 234 to a control system that isconfigured (e.g., with one or more processors) to supply the windings232 with current in an ordered fashion to efficiently energize thewindings to drive the rotor 228. The control system can be part of thecontroller 22. The rotor 228 can be coupled with a shaft 236 to drivethe working end of the catheter pump 10. For example, the shaft 236 canbe coupled with or can include the proximal end of the drive shaft 208.In another embodiment, the shaft 236 is coupled with a drive componentof a transmission including a tension member, as discussed further belowin connection with FIGS. 15-17.

The motor assembly 14A can include a sensor 237 that is disposed in themagnetic field of the armature assembly 230 and/or the rotor 228. Thesensor 237 can provide feedback to the motor control system, which maybe part of the controller 22, to assist in driving the windings of thearmature assembly 230. The motor assembly 14A can include a housing 238in which the armature assembly 230 and rotor 228 are disposed. Thehousing 238 can include a first recess configured to receive a firstportion of the armature assembly 230 and a cap 239 configured to receivea second portion of the armature assembly 230. The housing 238 and cap239 hold the first and second portions and thereby.

In FIG. 8, the drive magnet 221 is illustrated in phantom, such that thedriven magnet 204 can be seen disposed within the drive magnet 221.Although not illustrated, the poles of the drive magnet 221 can beformed on an interior surface of the drive magnet 221, and the poles ofthe driven magnet 204 can be formed on an exterior surface of the drivenmagnet 204. As the drive magnet 221 rotates, the poles of the drivemagnet 221 can magnetically engage with corresponding, opposite poles ofthe driven magnet 204 to cause the driven magnet 204 to rotate with, orfollow, the drive magnet 221. Because the driven magnet 204 can bemechanically coupled to the drive shaft 208, rotation of the drivemagnet 221 can cause the driven magnet 204 and the drive shaft 208 torotate at a speed determined in part by the speed of the motor 220.Furthermore, when the driven magnet 204 is inserted into the drivemagnet 221, the poles of each magnet can cause the drive magnet 221 andthe driven magnet 204 to self-align. The magnetic forces between thedrive magnet 221 and the driven magnet 204 can assist in coupling thedrive assembly 203 to the driven assembly 201.

Turning to FIG. 9, a 3D perspective view of various components at theinterface between the drive assembly 203 and the driven assembly 201 isshown. Various components have been hidden to facilitate illustration ofone means to secure the drive assembly 203 to the driven assembly 201. Afirst securement device 240 is illustrated in FIG. 9. The firstsecurement device can comprise a first projection 240 a and a secondprojection 240 b. Furthermore, a locking recess 244 can be formed in thecap 212 around at least a portion of a perimeter of the opening 202. Alip 242 can also extend from the perimeter at least partially into theopening 202. As shown, the lip 242 can also extend proximally from thelocking recess 244 such that a step is formed between the locking recess244 and the lip 242. Further, a flange 246 can be coupled to or formedintegrally with the flow diverter housing 207. In certain embodiments,the flange 246 can include a plurality of apertures 247 a, 247 b, 247 c,247 d that are configured to permit tubes and cables to passtherethrough to fluidly communicate with lumens within the flow diverter205. In some implementations, three tubes and one electrical cable canpass through the apertures 247 a-d. For example, the electrical cablecan be configured to electrically couple to a sensor within the catheterassembly 100A, e.g., a pressure sensor. The three tubes can beconfigured to carry fluid to and from the catheter assembly 100A. Forexample, a first tube can be configured to carry infusate into thecatheter assembly 100A, a second tube can be configured to transportfluids to the pressure sensor region, and the third tube can beconfigured to transport waste fluid out of the catheter assembly 100A.In other embodiments, one or more fluid passages may provide fluidcommunication between fluid channels in the catheter assembly 100A and aproximal portion of a transmission or drive component as discussed belowin connection with FIGS. 15-17. For example, as discussed below a fluidconduit can be coupled with a proximal port of a shaft in a drivecomponent or transmission to convey waste fluid to a waste container.Although not illustrated, the tubes and cable(s) can pass through theapertures 247 a-d of the flange 246 and can rest against the motorhousing 211. By organizing the routing of the tubes and cable(s), theapertures 247 a-d can advantageously prevent the tubes and cable(s) frombecoming entangled with one another or with other components of thecatheter pump system.

When the driven assembly 201 is inserted into the opening 202, the firstand second projections 240 a, 240 b can pass through the opening andengage the locking recess 244. In some implementations, the projections240 a, 240 b and the locking recess 244 can be sized and shaped suchthat axial translation of the projections 240 a, 240 b through theopening 202 causes a flange or tab 248 at a distal end of eachprojection 240 a, 240 b to extend over the locking recess 244. Thus, insome embodiments, once the projections 240 a, 240 b are inserted throughthe opening 202, the tabs 248 at the distal end of the projections 240a, 240 b are biased to deform radially outward to engage the lockingrecess 244 to secure the driven assembly 201 to the drive assembly 203.

Once the driven assembly 201 is secured to the drive assembly 203, theflow diverter housing 207 can be rotated relative to the motor cap 212.By permitting relative rotation between the driven assembly 201 and thedrive assembly 203, the clinician is able to position the impellerassembly 116A within the patient at a desired angle or configuration toachieve the best pumping performance. As shown in FIG. 9, however, thelip 242 can act to restrict the relative rotation between the drivenassembly 201 (e.g., the flow diverter housing 207) and the driveassembly 203 (e.g. the cap 212 and the motor housing 211). Asillustrated, the flange 246 and apertures 247 a-d can becircumferentially aligned with the projections 240 a, 240 b. Further,the lip 242 can be circumferentially aligned with the sliding member213, the track 214, and the connector 291 of the motor housing 211. Ifthe flange 246 and projections 240 a, 240 b are rotated such that theycircumferentially align with the lip 242, then the tubes and cable(s)that extend from the apertures 247 a-d may become entangled with orotherwise obstructed by the sliding member 213 and the connector 291.Thus, it can be advantageous to ensure that the sliding member 213 andthe connector 291 (or any other components on the outer surface of thehousing 211) do not interfere or obstruct the tubes and cable(s)extending out of the apertures 247 a-d of the flange 246. The lip 242formed in the cap 212 can act to solve this problem by ensuring that theflange 246 is circumferentially offset from the sliding member 213 andthe connector 291. For example, the flow diverter housing 207 can berotated until one of the projections 240 a, 240 b bears against a sideof the lip 242. By preventing further rotation beyond the side of thelip 242, the lip 242 can ensure that the flange 246 and apertures 247a-d are circumferentially offset from the sliding member 213, the track214, and the connector 291.

In one embodiment, once the catheter assembly 100A is secured to themotor housing 211, the connection between the driven assembly 201 andthe drive assembly 203 may be configured such that the drive assembly203 may not be removed from the driven assembly 201. The secureconnection between the two assemblies can advantageously ensure that themotor housing 211 is not accidentally disengaged from the catheterassembly 100A during a medical procedure. In such embodiments, both thecatheter assembly 100A and the drive assembly 203 may preferably bedisposable.

In other embodiments, however, it may be desirable to utilize are-usable drive assembly 203. In such embodiments, therefore, the driveassembly 203 may be removably engaged with the catheter assembly 100A(e.g., engaged with the driven assembly 201). For example, the lip 242may be sized and shaped such that when the drive assembly 203 is rotatedrelative to the driven assembly 201, the tabs 248 are deflected radiallyinward over the lip 242 such that the driven assembly 201 can bewithdrawn from the opening 202. For example, the lip 242 may include aramped portion along the sides of the lip 242 to urge the projections240 a, 240 b radially inward. It should be appreciated that otherrelease mechanisms are possible.

Turning to FIGS. 10A-10C, an additional means to secure the driveassembly 203 to the driven assembly 201 is disclosed. As shown in the 3Dperspective view of FIG. 10A, a locking O-ring 253 can be mounted to thebarrier 224 that is disposed within the motor housing 211 and at leastpartially within the cap 212. In particular, the locking O-ring 253 canbe mounted on an inner surface of the drive or motor housing 203surrounding the recess or opening 202 into which the driven assembly 212can be received As explained below, the locking O-ring can act as adetent mechanism and can be configured to be secured within an arcuatechannel formed in an outer surface of the driven assembly 201, e.g., inan outer surface of the flow diverter 205 in some embodiments. In otherembodiments, various other mechanisms can act as a detent to secure thedriven assembly 201 to the drive assembly 203. For example, in oneembodiment, a spring plunger or other type of spring-loaded feature maybe cut or molded into the barrier 224, in a manner similar to thelocking O-ring 253 of FIGS. 10A-10C. The spring plunger or spring-loadedfeature can be configured to engage the arcuate channel, as explainedbelow with respect to FIG. 10C. Skilled artisans will understand thatother types of detent mechanisms can be employed.

FIG. 10B illustrates the same 3D perspective of the drive assembly 203as shown in FIG. 10A, except the cap 212 has been hidden to betterillustrate the locking O-ring 253 and a second, stabilizing O-ring 255.The O-ring 255 is an example of a damper that can be provided betweenthe motor 220 and the catheter assembly 100A. The damper can provide avibration absorbing benefit in some embodiments. In other embodiment,the damper may reduce noise when the pump is operating. The damper canalso both absorb vibration and reduce noise in some embodiments. Thestabilizing O-ring 255 can be disposed within the cap 212 and can besized and shaped to fit along the inner recess forming the innerperimeter of the cap 212. The stabilizing O-ring 255 can be configuredto stabilize the cap 212 and the motor housing 211 against vibrationsinduced by operation of the motor 220. For example, as the motor housing211 and/or cap 212 vibrate, the stabilizing O-ring 255 can absorb thevibrations transmitted through the cap 212. The stabilizing O-ring 255can support the cap 212 to prevent the cap from deforming or deflectingin response to vibrations. In some implementations, the O-ring 255 canact to dampen the vibrations, which can be significant given the highrotational speeds involved in the exemplary device.

In further embodiments, a damping material can also be applied aroundthe motor 220 to further dampen vibrations. The damping material can beany suitable damping material, e.g., a visco-elastic or elastic polymer.For example, the damping material may be applied between the motor mount226 and the motor 220 in some embodiments. In addition, the dampingmaterial may also be applied around the body of the motor 220 betweenthe motor 220 and the motor housing 211. In some implementations, thedamping material may be captured by a rib formed in the motor housing211. The rib may be formed around the motor 220 in some embodiments.

Turning to FIG. 10C, a proximal end of the driven assembly 201 is shown.As explained above, the flow diverter 205 (or the flow diverter housingin some embodiments) can include an arcuate channel 263 formed in anouter surface of the flow diverter 205. The arcuate channel 263 can besized and shaped to receive the locking O-ring 253 when the flowdiverter 205 is inserted into the opening 202 of the drive assembly 203.As the flow diverter 205 is axially translated through the recess oropening 202, the locking O-ring 253 can be urged or slid over an edge ofthe channel 263 and can be retained in the arcuate channel 263. Thus,the locking O-ring 253 and the arcuate channel 263 can operate to act asa second securement device. Axial forces applied to the motor assembly206 can thereby be mechanically resisted, as the walls of the arcuatechannel 263 bear against the locking O-ring 253 to prevent the lockingO-ring 253 from translating relative to the arcuate channel 263. Invarious arrangements, other internal locking mechanisms (e.g., withinthe driven assembly 201 and/or the drive assembly 203) can be providedto secure the driven and drive assemblies 201, 203 together. Forexample, the driven magnet 204 and the drive magnet 221 may beconfigured to assist in securing the two assemblies together, inaddition to aligning the poles of the magnets. Other internal lockingmechanisms may be suitable.

FIG. 10C also illustrates a resealable member 266 disposed within theproximal end portion of the driven assembly 201, e.g., the proximal endof the catheter assembly 100A as shown in FIG. 4. As in FIG. 4, theproximal guidewire opening 237 can be formed in the resealable member266. As explained above with respect to FIG. 4, the guidewire 235 can beinserted through the proximal guidewire opening 237 and can bemaneuvered through the patient's vasculature. After guiding theoperative device of the pump to the heart, the guidewire 235 can beremoved from the catheter assembly 100A by pulling the guidewire 235 outthrough the proximal guidewire opening 237. Because fluid may beintroduced into the flow diverter 205, it can be advantageous to sealthe proximal end of the flow diverter 205 to prevent fluid from leakingout of the catheter assembly 100A. The resealable member 266 cantherefore be formed of an elastic, self-sealing material that is capableof closing and sealing the proximal guidewire opening 237 when theguidewire 235 is removed. The resealable member can be formed of anysuitable material, such as an elastomeric material. In someimplementations, the resealable member 266 can be formed of any suitablepolymer, e.g., a silicone or polyisoprene polymer. Skilled artisans willunderstand that other suitable materials may be used.

FIG. 11 illustrates yet another embodiment of a motor assembly 206Acoupled to a catheter assembly. In FIG. 11, a flow diverter is disposedover and coupled to a catheter body 271 that can include a multi-lumensheath configured to transport fluids into and away from the catheterassembly. The flow diverter 205A can provide support to the catheterbody 271 and a drive shaft configured to drive the impeller assembly.Further, the motor assembly 206A can include a motor 220A that has ahollow lumen therethrough. Unlike the embodiments disclosed in FIGS.4-10C, the guidewire 235 may extend through the proximal guidewireopening 237A formed proximal to the motor 220A, rather than between themotor 220A and the flow diverter 205A. A resealable member 266A may beformed in the proximal guidewire opening 237A such that the resealablemember 266A can close the opening 237A when the guidewire 235 is removedfrom the catheter assembly. A rotary seal 273 may be disposed inside alip of the flow diverter 205A. The rotary seal 273 may be disposed overand may contact a motor shaft extending from the motor 220A. The rotaryseal 273 can act to seal fluid within the flow diverter 205A. In someembodiments, a hydrodynamic seal can be created to prevent fluid frombreaching the rotary seal 273.

In the implementation of FIG. 11, the motor 220A can be permanentlysecured to the flow diverter 205A and catheter assembly. Because theproximal guidewire opening 237 is positioned proximal the motor, themotor 220A need not be coupled with the catheter assembly in a separatecoupling step. The motor 220A and the catheter assembly can thus bedisposable in this embodiment. The motor 220A can include an outputshaft and rotor magnetically coupled with a rotatable magnet in the flowdiverter 205A. The motor 220A can also include a plurality of windingsthat are energized to directly drive the rotatable magnet in the flowdiverter 205A. In variations of the embodiment of FIG. 11, the motor220A is permanently attached to the flow diverter but is off-set toprovide one or more benefits to the motor assembly 206A. For example,the off-set position enables better support of the rotational componentswithin the flow diverter or housing for the motor.

FIGS. 12A-12B illustrate another embodiment of a motor coupling having adriven assembly 401 and a drive assembly 403. Unlike the implementationsdisclosed in FIGS. 4-10C, however, the embodiment of FIGS. 12A-12B caninclude a mechanical coupling disposed between an output shaft of amotor and a proximal end of a flexible drive shaft or cable. Unlike theimplementations disclosed in FIG. 11, however, the embodiment of FIGS.12A-12B can include a guidewire guide tube that terminates at a locationdistal to a motor shaft 476 that extends from a motor 420. As best shownin FIG. 12B, an adapter shaft 472 can operably couple to the motor shaft476 extending from the motor 420. A distal end portion 477 of theadapter shaft 472 can mechanically couple to a proximal portion of anextension shaft 471 having a central lumen 478 therethrough. As shown inFIG. 12B, one or more trajectories 473 can be formed in channels withina motor housing 475 at an angle to the central lumen 478 of theextension shaft 471. The motor housing 475 can enclose at least theadapter shaft 472 and can include one or more slots 474 formed through awall of the housing 475.

In some implementations, a guidewire (not shown in FIG. 12B) may passthrough the guidewire guide tube from the distal end portion of thecatheter assembly and may exit the assembly through the central lumen478 near the distal end portion 477 of the adapter shaft 472 (or,alternatively, near the proximal end portion of the extension shaft471). In some embodiments, one of the extension shaft 471 and theadapter shaft 472 may include a resealable member disposed therein toreseal the lumen through which the guidewire passes, as explained above.In some embodiments, the extension shaft 471 and the adapter shaft 472can be combined into a single structure. When the guidewire exits thecentral lumen 478, the guidewire can pass along the angled trajectories473 which can be formed in channels and can further pass through theslots 474 to the outside environs. The trajectories 473 can follow fromangled ports in the adapter shaft 472. A clinician can thereby pull theguidewire through the slots 474 such that the end of the guidewire caneasily be pulled from the patient after guiding the catheter assembly tothe heart chamber or other desired location. Because the guidewire mayextend out the side of the housing 475 through the slots, the motorshaft 476 and motor 420 need not include a central lumen for housing theguidewire. Rather, the motor shaft 476 may be solid and the guidewirecan simply pass through the slots 474 formed in the side of the housing475.

Furthermore, the drive assembly 403 can mechanically couple to thedriven assembly 401. For example, a distal end portion 479 of theextension shaft 471 may be inserted into an opening in a flow diverterhousing 455. The distal end portion 479 of the extension shaft 471 maybe positioned within a recess 451 and may couple to a proximal end of adrive cable 450 that is mechanically coupled to the impeller assembly. Arotary seal 461 may be positioned around the opening and can beconfigured to seal the motor 420 and/or motor housing 475 from fluidwithin the flow diverter 405. Advantageously, the embodiments of FIGS.12A-B allow the motor 420 to be positioned proximal of the rotary sealin order to minimize or prevent exposing the motor 420 to fluid that mayinadvertently leak from the flow diverter. It should be appreciated thatthe extension shaft 471 may be lengthened in order to further isolate orseparate the motor 420 from the fluid diverter 405 in order to minimizethe risk of leaking fluids. In other variations, the motor 420 isoff-set from the proximal end of the driven assembly 401. For example, atension member or other lateral drive component can be provided toengage the output shaft of the motor 420 with the driven assembly 401. Abelt or other tension member (shown, e.g., in FIG. 16) can couple theoutput shaft with the driven assembly 401. Other lateral drivearrangements (e.g., arrangements where the motor mounted off of therotational axis of the driven assembly 401) can employ one or moredirect engagement components such as gears.

Turning to FIG. 13, further features that may be included in variousembodiments are disclosed. FIG. 13 illustrates a distal end portion 300of a catheter assembly, such as the catheter assembly 100A describedabove. As shown a cannula housing 302 can couple to a distal tip member304. The distal tip member 304 can be configured to assist in guidingthe operative device of the catheter assembly, e.g., an impellerassembly (which can be similar to or the same as impeller assembly116A), along the guidewire 235. The exemplary distal tip member 304 isformed of a flexible material and has a rounded end to prevent injury tothe surrounding tissue. If the distal tip member 304 contacts a portionof the patient's anatomy (such as a heart wall or an arterial wall), thedistal tip member 304 will safely deform or bend without harming thepatient. The tip can also serve to space the operative device away fromthe tissue wall. In addition, a guidewire guide tube 312, discussedabove with reference to FIG. 4, can extend through a central lumen ofthe catheter assembly. Thus, the guidewire guide tube 312 can passthrough the impeller shaft (not shown, as the impeller is locatedproximal to the distal end portion 300 shown in FIG. 13) and a lumenformed within the distal tip member 304. In the embodiment of FIG. 13,the guidewire guide tube 312 may extend distally past the distal end ofthe distal tip member 304. As explained above, in various embodiments,the clinician can introduce a proximal end of the guidewire into thedistal end of the guidewire guide tube 312, which in FIG. 13 extendsdistally beyond the tip member 304. Once the guidewire 235 has beeninserted into the patient, the guidewire guide tube 312 can be removedfrom the catheter assembly in some implementations.

The distal tip member 304 can comprise a flexible, central body 306, aproximal coupling member 308, and a rounded tip 310 at the distal end ofthe tip member 304. The central body 306 can provide structural supportfor the distal tip member 304. The proximal coupling member 308 can becoupled to or integrally formed with the central body 306. The proximalcoupling member 308 can be configured to couple the distal end of thecannula housing 302 to the distal tip member 304. The rounded tip 310,also referred to as a ball tip, can be integrally formed with thecentral body 306 at a distal end of the tip member 304. Because therounded tip 310 is flexible and has a round shape, if the tip member 304contacts or interacts with the patient's anatomy, the rounded tip 310can have sufficient compliance so as to deflect away from the anatomyinstead of puncturing or otherwise injuring the anatomy. As comparedwith other potential implementations, the distal tip member 304 canadvantageously include sufficient structure by way of the central body306 such that the tip member 304 can accurately track the guidewire 235to position the impeller assembly within the heart. Yet, because the tipmember 304 is made of a flexible material and includes the rounded tip310, any mechanical interactions with the anatomy can be clinically safefor the patient.

One potential problem with the embodiment of FIG. 13 is that it can bedifficult for the clinician to insert the guidewire into the narrowlumen of the guidewire guide tube 312. Since the guidewire guide tube312 has a small inner diameter relative to the size of the clinician'shands, the clinician may have trouble inserting the guidewire into thedistal end of the guidewire guide tube 312, which extends past thedistal end of the tip member 304 in FIG. 13. In addition, when theclinician inserts the guidewire into the guidewire guide tube 312, thedistal edges of the guidewire guide tube 312 may scratch or partiallyremove a protective coating applied on the exterior surface of theguidewire. Damage to the coating on the guidewire may harm the patientas the partially uncoated guidewire is passed through the patient'svasculature. Accordingly, it can be desirable in various arrangements tomake it easier for the clinician to insert the guidewire into the distalend of the catheter assembly, and/or to permit insertion of theguidewire into the catheter assembly while maintaining the protectivecoating on the guidewire.

Additionally, as explained herein, the cannula housing 302 (which mayform part of an operative device) may be collapsed into a storedconfiguration in some embodiments such that the cannula housing isdisposed within an outer sheath. When the cannula housing 302 isdisposed within the outer sheath, a distal end or edge of the outersheath may abut the tip member 304. In some cases, the distal edge ofthe outer sheath may extend over the tip member 304A, or the sheath mayhave an outer diameter such that the distal edge of the outer sheath isexposed. When the sheath is advanced through the patient's vasculature,the distal edge of the outer sheath may scratch, scrape, or otherwiseharm the anatomy. There is a therefore a need to prevent harm to thepatient's anatomy due to scraping of the distal edge of the sheathagainst the vasculature.

FIG. 14 is a side cross-sectional view of a distal tip member 304Adisposed at a distal end 300A of the catheter assembly, according toanother embodiment. Unless otherwise noted, the reference numerals inFIG. 14 may refer to components similar to or the same as those in FIG.13. For example, as with FIG. 13, the distal tip member 304A can coupleto a cannula housing 302A. The distal tip member 304A can include aflexible, central body 306A, a proximal coupling member 308A, and arounded tip 310A at the distal end of the tip member 304A. Furthermore,as with FIG. 13, a guidewire guide tube 312A can pass through thecannula housing 302A and a lumen passing through the distal tip member304A.

However, unlike the embodiment of FIG. 13, the central body 306A caninclude a bump 314 disposed near a proximal portion of the tip member304A. The bump 314 illustrated in FIG. 14 may advantageously prevent theouter sheath from scraping or scratching the anatomy when the sheath isadvanced through the patient's vascular system. For example, when thecannula housing 302A is disposed within the outer sheath, the sheathwill advance over the cannula housing 302A such that the distal edge orend of the sheath will abut or be adjacent the bump 314 of the tipmember 304A. The bump 314 can act to shield the patient's anatomy fromsharp edges of the outer sheath as the distal end 300A is advancedthrough the patient. Further, the patient may not be harmed when thebump 314 interact with the anatomy, because the bump 314 includes arounded, smooth profile. Accordingly, the bump 314 in FIG. 14 mayadvantageously improve patient outcomes by further protecting thepatient's anatomy.

Furthermore, the guidewire guide tube 312A of FIG. 14 does not extenddistally past the end of the tip member 306A. Rather, in FIG. 14, thecentral lumen passing through the tip member 304A may include a proximallumen 315 and a distal lumen 313. As shown in FIG. 14, the proximallumen 315 may have an inner diameter larger than an inner diameter ofthe distal lumen 313. A stepped portion or shoulder 311 may define thetransition between the proximal lumen 315 and the distal lumen 313. Asillustrated in FIG. 14, the inner diameter of the proximal lumen 315 issized to accommodate the guidewire guide tube 312A as it passes througha portion of the tip member 304A. However, the inner diameter of thedistal lumen 313 in FIG. 14 is sized to be smaller than the outerdiameter of the guidewire guide tube 312A such that the guidewire guidetube 312A is too large to pass through the distal lumen 313 of the tipmember 304A. In addition, in some embodiments, the thickness of theguidewire guide tube 312A may be made smaller than the height of thestepped portion or shoulder 311, e.g., smaller than the differencebetween the inner diameter of the proximal lumen 315 and the innerdiameter of the distal lumen 313. By housing the guidewire guide tube312A against the shoulder 311, the shoulder 311 can protect the outercoating of the guidewire when the guidewire is inserted proximally fromthe distal lumen 313 to the proximal lumen 315.

The embodiment illustrated in FIG. 14 may assist the clinician ininserting the guidewire (e.g., the guidewire 235 described above) intothe distal end 300A of the catheter assembly. For example, in FIG. 14,the guidewire guide tube 312A may be inserted through the central lumenof the catheter assembly. For example, the guidewire guide tube 312A maypass distally through a portion of the motor, the catheter body, theimpeller assembly and cannula housing 302A, and through the proximallumen 315 of the tip member 304A. The guidewire guide tube 312A may beurged further distally until the distal end of the guidewire guide tube312A reaches the shoulder 311. When the distal end of the guidewireguide tube 312A reaches the shoulder 311, the shoulder 311 may preventfurther insertion of the guidewire guide tube 312 in the distaldirection. Because the inner diameter of the distal lumen 313 is smallerthan the outer diameter of the guidewire guide tube 312A, the distal endof the guidewire guide tube 312A may be disposed just proximal of theshoulder 311, as shown in FIG. 14.

The clinician may insert the proximal end of the guidewire (such as theguidewire 235 described above) proximally through the distal lumen 313passing through the rounded tip 310A at the distal end of the tip member304A. Because the tip member 304A is flexible, the clinician can easilybend or otherwise manipulate the distal end of the tip member 304A toaccommodate the small guidewire. Unlike the guidewire guide tube 312A,which may be generally stiffer than the tip member 304A, the clinicianmay easily deform the tip member 304A to urge the guidewire into thedistal lumen 313. Once the guidewire is inserted in the distal lumen313, the clinician can urge the guidewire proximally past the steppedportion 311 and into the larger guidewire guide tube 312A, which may bepositioned within the proximal lumen 315. Furthermore, since mostcommercial guidewires include a coating (e.g. a hydrophilic orantomicrobial coating, or PTFE coating), the exemplary guide tube andshoulder advantageously avoid damaging or removing the coating. When thewall thickness of the guidewire guide tube 312A is less than the heightof the step or shoulder 311, the shoulder 311 may substantially preventthe guidewire guide tube 312A from scraping the exterior coating off ofthe guidewire. Instead, the guidewire easily passes from the distallumen 313 to the proximal lumen 315. The guidewire may then be urgedproximally through the impeller and catheter assembly until theguidewire protrudes from the proximal end of the system, such as throughthe proximal guidewire opening 237 described above with reference toFIG. 4.

FIGS. 15-17 illustrate features of further embodiments in connectionwith a catheter pump assembly 500. In various respects, catheter pumpassembly 500 is similar to catheter assembly 100A described above,except it includes a modified drive system 504. The assembly 500includes the catheter assembly 100A discussed above, in some cases withsome modifications as discussed below. In one variation the catheterpump assembly 500 includes a drive system 504 and a fluid removal system508. In various respects, drive system 504 is similar to drive system206 described above. The fluid removal system 508 can be part of anoperating fluid system, for example incorporating components of theinfusion system 26 discussed above and any of the additional featuresdiscussed below. The drive system 504 includes a motor assembly 512 anda transmission assembly 516 that allows the motor assembly 512 to bepositioned away from or off-axis from the proximal end of the catheterassembly 100A.

In one variation the motor assembly 512 includes a housing 524 having amotor unit 528 disposed therein. The motor unit 528 includes an electricmotor 532 that is electrically coupled with and controlled by acontroller, e.g., by the controller 22. The housing 524 is sufficientlyrigid and stable to reduce or minimize external vibrations or otherenvironmental conditions from affecting the operation of the electricmotor 532 or the components mechanically coupled therewith. This can beimportant to ensure the forces experienced by motor are absorbed by thehousing and transmitted to stabilizing platform instead of beingtranslated through the catheter pump assembly. One or more motor mounts538 also can be provided to secure the motor 532 within the housing 524.The motor 532 can include an output shaft 540 that is rotated by a rotorof the motor 532. A drive component 548 is coupled with, e.g., mountedon, the output shaft 540 such that the shaft 540 and the drive component548 are rotated about a first axis 552.

The transmission assembly 516 can be located at least in part in ahousing 564 that is separate from the housing 524. In one embodiment,the housing 564 has a shaft 568 disposed therein and journaled forrotation. The shaft 568 can be supported by bearings 570 disposed onproximal and distal ends thereof. In one embodiment, a driven component572 can be coupled with, e.g., mounted on, the shaft 568. The shaft 568and the driven component 572 can freely rotate in the housing 564 abouta second axis 576, which can be offset from the first axis 552.

The shaft 568 preferably includes a lumen that can be fluidly coupled ata distal end thereof with a proximal portion of the infusion oroperating fluid system 26 and at a proximal end thereof with a conduit584 to convey the fluid to a waste vessel 588. The lumen in the shaft,the conduit 584 and the vessel 588 can all be part of the fluid removalsystem 508. In certain embodiment, the operating fluid from the system26 is directed into the catheter assembly 100A and at least a portionflows proximally over certain components of the catheter assembly 100A.For example, a rotatable magnet can be mounted to rotate in the flowdiverter housing 207. This rotating structure is sometimes referred toherein as a rotor. In order to provide smooth and durable operation itis desirable to subject the rotor to a fluid to cool and/or lubricatethe rotor. This fluid flows most efficiently within the catheterassembly 100A if it can flow in a distal to proximal path within thecatheter assembly 100A. For example, one advantageous path isillustrated by arrow A from a distal end of the rotor to a proximal endof the rotor, and thereafter into the lumen in the shaft 568 and out ofthe transmission assembly 516. US Patent Application Publication No.2012/0178986 is incorporated by reference herein in its entirety for allpurposes, and in some respects for additional discussion of flow pathsin connection with rotors.

The driven component 572 can be located in a proximal portion of thehousings 564. The driven component 572 and the drive component 548comprise working portions of a power train between the motor and thecatheter assembly 100A. These component can take a conventional form,e.g., as gears, sprockets, pulleys, or variable torque members.

A distal portion of the housing 564 can enclose a drive component 596configured to be rotated with the shaft 568. The drive component 596 issometimes described as a second drive component and the drive component548 is sometimes referred to as a first drive component herein. The useof “first” and “second” in this context is arbitrary with the “first”member being closer to the source of torque, e.g., the motor 532. Thedrive component 596 is configured to be engaged with the proximal end ofthe catheter assembly 100A in the same way discussed above, e.g., withpaired permanent magnets, or with gears or other direct contactmechanical interface. For example, the drive component 596 can comprisea cup-like structure that can receive the proximal end of the catheterassembly 100A. When so received, a driven component of the catheterassembly 100A such as a rotor or other member including magnets, such asthe magnets 204, is engaged with the drive component 596.

FIGS. 15 and 16 show that the catheter pump assembly 500 includes atension member 604 that extends between the motor assembly 512 and thedriven component 572 of the transmission assembly 516. The tensionmember 604 can be considered part of the transmission assembly 516. Thedriven component 572, which can include or be coupled with the magnets204, can be coupled with an elongate flexible member such as the driveshaft 208. The tension member 604 can be coupled with the motor unit 528and with the driven component 572, including the magnet or magnets 204,to cause the driven component 572 to rotate when the motor 532 rotatesand thereby cause the drive shaft 208 (or other elongate flexiblemember) and the impeller assembly 92 to rotate.

The tension member 604 can take any suitable form that is suitable fortransferring torque between the drive and driven members 548, 572 aswill be understood by one of skill from the description herein. Forexample, the tension member 604 can comprise a drive belt such as atooth belt, a cog belt, a notch belt, a V-belt. The tension member 604can comprise a chain or other flexible driving member. In an embodimentwhere the tension member 604 is a chain, a tooth belt, a cog belt, anotch belt, or similar structure, the drive and driven members 548, 572can be cogs.

FIGS. 15-17 illustrate the pump catheter pump assembly 500 comprisingtwo separate housings. In other embodiment the transmission assembly 516and the motor assembly 512 are disposed in the same housing. Separate orseparable housings are advantageous in facilitating one or morere-usable components. For example, in one embodiment, the transmissionassembly 516 is reusable. In another embodiment, the motor assembly 512is reusable. In some embodiments, the transmission assembly 516 can beused a first number of times. In some embodiments, the motor assembly512 can be used a second number of times greater than the first numberof times.

The motor assemblies discussed herein and systems incorporating themprovide many advantages. For example, sterilizing the components of thecatheter pumps incorporating one or more features discussed herein canbe facilitated by separating the driven assembly 201 from the motor unit528 or the motor assembly 14A, That is, in various methods of use, acatheter assembly can be sterilized apart from a motor assembly or motorunit and/or transmission assembly. In various methods of use, the motorassembly or motor unit and/or transmission assembly can be sterilizedand reused whereas the catheter assembly can be disposable. By providingtransfer of rotation through a tension member, the drive componentscoupled with the motor unit or motor assembly and coupled with theproximal end of the catheter assembly can easily be decoupled ordisassembled for separate sterilization.

Further, as discussed above the using a tension member to transfertorque from the motor unit or motor assembly provides for isolation orinsulation between the catheter assembly and the motor. Mechanicalisolation of the motor from the catheter assembly is useful in that dueto normal manufacturing variation in the components of the motor, theremay be noticeable vibration upon operation of the motor. The tensionmember can absorb some of that vibration and reduce the amplitude orfrequency of the vibration as felt by the catheter assembly. Also, thedrive component coupled with the proximal end of the catheter assemblycan be better supported so that such drive component has less or noeccentricity in rotation.

The separation of the motor unit or motor assembly from the catheterassembly also enables isolation of the heat of the motor from theproximal end of the catheter assembly. Certain advantageous motordesigns generate significant heat. For example, the motor assembly 14Ainduces rotation by driving current through coils to generate magneticfields. It is preferred that the proximal end of the catheter assemblybe adjacent to the patient, and in some cases mounted on the patient'sleg or otherwise directly contacting the patient. The off-setpositioning of the motor assembly 14A enables the heat generatingcomponents to be isolated or insulated from the patient while stillpermitting the proximal end of the catheter assembly to be at or on thepatient. Regardless of the type of motor used, higher speeds generallygenerate more heat. Therefore, for higher rotational speeds it is moreimportant to provide for heat isolation or insulation between the heatgenerating components (e.g., the motor or mechanical bearings) and thepatient. In at least this sense, these arrangements insulate thecomponents from each other. By reducing or minimizing heat transfer fromthe motor unit or motor assembly to the catheter assembly heating offluids in the catheter assembly is reduced or minimized which canfacilitate longer operation, higher biocompatibility, and/or moreconvenient operation by the medical staff overseeing the use of thecatheter pumps described herein.

The off-set positioning of the motor unit or motor assembly also allowsthe movements of the catheter assembly to not be felt by or to be onlyminimally felt by the motor unit or motor assembly. Any such movement orheat generated by the catheter assembly can be isolated from and thusprevented from compromising or damaging the motor.

The structures above provide for modular use of components. For examplerobust locking devices can be provided between housings (see, e.g., thestructures of FIG. 9 and corresponding description) enabling thecatheter assembly can be securely connected to a transmission assembly.As such any of the transmission assembly, a tension member (such as abelt), and a motor assembly or motor unit can be reused one or moretimes while the catheter assembly will generally be disposed of in eachuse.

By providing the motor unit or motor assembly offset from the proximalend of the catheter assembly, enhanced sealing and operating fluidremoval can be provided. FIG. 16 shows that operating fluid can beremoved from the proximal end of the catheter assembly rather than beingdiverted through a more complex manifold out of a side portion of thecatheter assembly. This relieves the need to pressure-seal the catheterassembly at a location distal of the drive component disposed within thecatheter assembly. This arrangement is also more tolerant of smallbreaches in seals. That is, the operating fluid may be a biocompatiblefluid such as saline. Such a fluid can be corrosive to the motor unit ormotor assembly. By off-setting the motor unit or motor assembly fromflow path of the operating fluid small leaks in fluid will not bedirected to the motor but rather will be located at or in thetransmission assembly. While this may limit the re-use of thetransmission assembly, the motor unit or motor assembly may beunaffected by minor seal breaches and thus can remain capable of re-use.

In certain embodiments, a guidewire passage is provided through anassembly including the catheter assembly and the transmission assembly.This passage enables easier access to a guidewire and in some casesreintroduction of a guidewire into a system when partially engaged. Inparticular, the transmission assembly may be coupled with the catheterassembly while retaining the ability to advance the catheter assemblyover the guidewire. This can be achieved by directing the guidewirethrough the same channel that the operating fluid flows, e.g., to exitthe proximal end of the catheter assembly and/or transmission assembly.This allows the clinician some flexibility in the order of assemblyand/or more convenient repositioning without fully disassembling themotor unit/assembly, transmission assembly, and catheter assembly.

These arrangements can help to reduce the cost of having and operatingthe catheter pump 10. For example, one or more components can be treatedas capital equipment with the cost of such components being defrayedover many uses. In specific implementations, the console, the motor unitor motor assembly, and the transmission assembly can be re-used manytimes and the catheter assembly and the tension member (e.g., belt) canbe disposed of after one or more uses.

Although the inventions herein have been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent inventions. It is therefore to be understood that numerousmodifications can be made to the illustrative embodiments and that otherarrangements can be devised without departing from the spirit and scopeof the present inventions as defined by the appended claims. Thus, it isintended that the present application cover the modifications andvariations of these embodiments and their equivalents.

1-10. (canceled)
 11. A catheter pump assembly, comprising: a catheterassembly, comprising: an elongate body having a proximal end and adistal end, a first lumen and a second lumen extending between theproximal and distal ends; an elongate flexible shaft having a proximalend and a distal end and extending through the first lumen; an impellerdisposed distal of the distal end of the elongate flexible shaft; adriven component coupled with the proximal end of the elongate flexibleshaft and supported for rotation adjacent to the proximal end of theelongate body and; and an outflow port disposed proximal of the drivencomponent; an operating fluid system including a source of operatingfluid in communication with the second lumen of the elongate body, theoperating fluid flowable into the second lumen and distally within theelongate body and thereafter proximally in the first lumen to cooland/or lubricate the elongate flexible drive shaft and the drivencomponent; and a drive system comprising a motor and a transmission fortransferring torque to the driven component, the motor disposedlaterally of the outflow port such that the operating fluid can beremoved from the catheter assembly through the outflow port proximallyof the driven component without flowing through the motor.
 12. Thecatheter pump assembly of claim 11, wherein the transmission comprises aflexible tension member disposed between a first speed and torquetransfer member disposed on an output shaft of the motor and a secondspeed and torque transfer member in driving engagement with the drivencomponent.
 13. The catheter pump assembly of claim 12, wherein thesecond speed and torque transfer member comprises a lumen in fluidcommunication with the outflow port.
 14. The catheter pump assembly ofclaim 13, wherein the second speed and torque transfer member comprisesa shaft having a hollow lumen and a driven member disposed on the shaft,the hollow lumen providing fluid communication upstream to the outflowport and second lumen and downstream to a waste vessel.
 15. The catheterpump assembly of claim 11, wherein a portion of the operating fluidflows distally within the first lumen. 16-19. (canceled)
 20. A catheterpump assembly comprising: a catheter assembly, comprising: an elongatebody having a proximal end and a distal end, a first lumen and a secondlumen extending between the proximal and distal ends; an elongateflexible shaft having a proximal end and a distal end and extendingthrough the first lumen; an impeller disposed distal of the distal endof the elongate flexible shaft; a driven component coupled with theproximal end of the elongate flexible shaft and supported for rotationadjacent to the proximal end of the elongate body and, the second lumenconfigured to channel operating fluid distally within the elongate bodyand thereafter proximally in the first lumen to cool and/or lubricatethe elongate flexible drive shaft and the driven component; and anoutflow port disposed proximal of the driven component; and a drivesystem comprising a motor and a transmission for transferring torque tothe driven component, the motor disposed laterally of the outflow portsuch that the operating fluid can be removed from the catheter assemblythrough the outflow port proximally of the driven component withoutflowing through the motor.
 21. The catheter pump assembly of claim 20,wherein the transmission comprises a flexible tension member disposedbetween a first speed and torque transfer member disposed on an outputshaft of the motor and a second speed and torque transfer member indriving engagement with the driven component.
 22. The catheter pumpassembly of claim 21, wherein the second speed and torque transfermember comprises a lumen in fluid communication with the outflow port.23. The catheter pump assembly of claim 22, wherein the second speed andtorque transfer member comprises a shaft having a hollow lumen and adriven member disposed on the shaft, the hollow lumen providing fluidcommunication upstream to the outflow port and second lumen anddownstream to a waste vessel.
 24. The catheter pump assembly of claim20, wherein a portion of the operating fluid flows distally within thefirst lumen.